HER2-positive Breast Cancer Clinical Trial
Official title:
A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer
and may have fewer side effects and improve recovery. Radiation therapy uses high-energy
x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells
that remain after surgery.
PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery
followed by radiation therapy works in treating patients with stage I or stage II breast
cancer.
PRIMARY OBJECTIVES:
I. To determine ipsilateral breast tumor recurrence rates as well as tumor bed recurrence
rates. Patients will be followed for a period of five years following completion of
radiation to determine these rates.
II. To determine the cosmetic outcome resulting from breast conserving surgery and breast
radiation.
SECONDARY OBJECTIVES:
I. To determine if there are patient factors which limit a patient's suitability to receive
breast conserving therapy in the setting of multi-centric disease.
II. To determine patient satisfaction of breast conserving therapy as it pertains to their
overall treatment experience as measured by a questionnaire.
III. To evaluate wound healing and overall complication rate after radiation as a component
of breast conserving therapy.
OUTLINE:
Patients undergo breast-conserving surgery consisting of partial mastectomies followed by
external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, then every 3 months
for 1 year, every 6 months for 1 year, and then annually for 5 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04095390 -
A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT04578106 -
Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
|
Phase 2 | |
| Completed |
NCT01855828 -
Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer
|
Phase 2 | |
| Terminated |
NCT01912963 -
Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer
|
Phase 2 | |
| Terminated |
NCT01705340 -
Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery
|
Phase 1 | |
| Recruiting |
NCT04094896 -
TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT06087120 -
Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
|
||
| Recruiting |
NCT05346861 -
Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab
|
Phase 3 | |
| Recruiting |
NCT04899908 -
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
|
Phase 2 | |
| Completed |
NCT03330561 -
PRS-343 in HER2-Positive Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04997798 -
Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT04034823 -
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT04756921 -
18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response
|
||
| Completed |
NCT03140553 -
TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT03094052 -
Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib
|
Phase 2 | |
| Recruiting |
NCT05511844 -
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05325632 -
Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
|
Phase 2 | |
| Recruiting |
NCT06161922 -
Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
|
||
| Recruiting |
NCT05710666 -
Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK Study)
|
Phase 2 | |
| Not yet recruiting |
NCT05063643 -
Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude
|